QC Investigations Specialist II at Legend Biotech

Raritan, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline
A minimum of 4 years relevant work experience, preferably within a biological and/or pharmaceutical industry
Experience in a Quality Control setting is preferred
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products
Knowledge of Good Tissue Practices
Detailed knowledge of CAR-T QC test methods and related equipment is preferred
Excellent written and oral communication skills
Ability to accommodate shift schedule, including routine weekend and evening work as required by the manufacturing process
Ability to accommodate unplanned overtime (including nights and weekends) on little to no prior notice
Highly organized and capable of working in a team environment with a positive attitude under some supervision
Comfortable with speaking and interacting with inspectors
Ability to travel occasionally to partner sites in NJ or PA as business demands (up to 10% domestic or international travel)

Responsibilities

Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise
Review/complete routine CAR-T manufacturing nonconformance/deviation investigations
Proactively work with stakeholders to implement effective CAPAs and ensure the timely completion of corrective and preventive actions within the laboratories
Provide recommendations for the improvement of processes by working cross-functionally with multiple stakeholders
Work closely with management to propose/execute improvements through the change management system
Respond with a high degree of urgency to departmental and cross-functional needs and requests
Report/monitor metrics on non-conformance investigations and corrective and preventive actions (CAPA)
Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements
Work in a collaborative team setting with quality counterparts that include Quality Assurance, Manufacturing Operations, and Analytical/Process Development

Skills

TrackWise

GMP

CAPA

Deviation Investigations

QC Testing

Laboratory Investigations

CAR-T Manufacturing

Nonconformance Management

Quality Control

Legend Biotech

Develops and commercializes cell therapies

About Legend Biotech

Legend Biotech develops and commercializes cell therapies aimed at treating serious diseases, particularly cancers like hematological malignancies and solid tumors. Their approach is technology agnostic, allowing them to explore various methods to find effective treatments. The company operates in the personalized medicine sector, focusing on discovering, developing, and bringing new therapies to market. They generate revenue through licensing and selling their therapies, including CAR-T therapies, which involve modifying a patient's cells to combat cancer. Legend Biotech emphasizes transparency with investors, regularly updating them on financial results and business developments.

Franklin Township, New JerseyHeadquarters

2014Year Founded

$146.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Sick Leave

Paid Holidays

Remote Work Options

Risks

Increased competition from Amgen's Imdelltra may impact CAR-T therapy focus.

Collaboration with Multiply Labs may face technological challenges, delaying production timelines.

Financial strain from new R&D facility could affect operational focus if advancements lag.

Differentiation

Legend Biotech focuses on novel cell therapies for oncology, including CAR-T and NK cells.

The company is technology agnostic, exploring multiple platforms for effective cancer treatments.

Legend Biotech's CARVYKTI® is the first BCMA-targeted CAR-T therapy approved for second-line use.

Upsides

Recent FDA and European approvals for CARVYKTI® expand its market reach in multiple myeloma.

New R&D facility in Philadelphia boosts innovation in next-generation cell therapies.

Alan Bash's appointment could accelerate CARVYKTI®'s growth and market penetration.

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